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A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis (OCTAVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01458574
First received: October 21, 2011
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Interventions: Drug: Placebo
Drug: CP690,550
Drug: CP-690,550

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tofacitinib 5 mg BID Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Tofacitinib 10 mg BID Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Placebo Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.

Participant Flow:   Overall Study
    Tofacitinib 5 mg BID   Tofacitinib 10 mg BID   Placebo
STARTED   198   197   198 
Treated   198   196   198 
COMPLETED   111   126   53 
NOT COMPLETED   87   71   145 
Adverse Event                5                9                7 
Lack of Efficacy                70                53                132 
Lost to Follow-up                3                2                1 
Pregnancy                1                1                0 
Protocol Violation                0                1                0 
Withdrawal by Subject                6                3                5 
Unspecified                2                1                0 
Randomized but not treated                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all randomized participants.

Reporting Groups
  Description
Tofacitinib 5 mg BID Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Tofacitinib 10 mg BID Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Placebo Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Total Total of all reporting groups

Baseline Measures
   Tofacitinib 5 mg BID   Tofacitinib 10 mg BID   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 198   197   198   593 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.9  (13.7)   42.9  (14.4)   43.4  (14)   42.7  (14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      95  48.0%      87  44.2%      82  41.4%      264  44.5% 
Male      103  52.0%      110  55.8%      116  58.6%      329  55.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants In Remission at Week 52   [ Time Frame: Week 52 ]

2.  Secondary:   Percentage of Participants With Mucosal Healing at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline   [ Time Frame: Week 24, 52 ]

4.  Secondary:   Percentage of Participants in Remission at Week 24   [ Time Frame: Week 24 ]

5.  Secondary:   Percentage of Participants in Sustained Remission   [ Time Frame: Week 24, 52 ]

6.  Secondary:   Percentage of Participants With Mucosal Healing at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:   Percentage of Participants With Sustained Mucosal Healing   [ Time Frame: Week 24, 52 ]

8.  Secondary:   Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline   [ Time Frame: Week 24, 52 ]

9.  Secondary:   Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline   [ Time Frame: Week 24, 52 ]

10.  Secondary:   Percentage of Participants With Clinical Response at Week 24 and 52   [ Time Frame: Week 24, 52 ]

11.  Secondary:   Percentage of Participants With Sustained Clinical Response   [ Time Frame: Week 24, 52 ]

12.  Secondary:   Percentage of Participants in Clinical Remission at Week 24 and 52   [ Time Frame: Week 24, 52 ]

13.  Secondary:   Percentage of Participants in Sustained Clinical Remission   [ Time Frame: Week 24, 52 ]

14.  Secondary:   Percentage of Participants in Deep Remission at Week 24 and 52   [ Time Frame: Week 24, 52 ]

15.  Secondary:   Percentage of Participants in Sustained Deep Remission   [ Time Frame: Week 24, 52 ]

16.  Secondary:   Percentage of Participants in Symptomatic Remission at Week 24 and 52   [ Time Frame: Week 24, 52 ]

17.  Secondary:   Percentage of Participants in Sustained Symptomatic Remission   [ Time Frame: Week 24, 52 ]

18.  Secondary:   Percentage of Participants in Endoscopic Remission at Week 24 and 52   [ Time Frame: Week 24, 52 ]

19.  Secondary:   Percentage of Participants in Sustained Endoscopic Remission   [ Time Frame: Week 24, 52 ]

20.  Secondary:   Total Mayo Score at Baseline, Week 24 and 52   [ Time Frame: Baseline, Week 24, 52 ]

21.  Secondary:   Change From Baseline in Total Mayo Score at Week 24 and 52   [ Time Frame: Baseline, Week 24, 52 ]

22.  Secondary:   Percentage of Participants in Remission, Among Participants With Remission at Baseline   [ Time Frame: Week 24, 52 ]

23.  Secondary:   Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline   [ Time Frame: Week 24, 52 ]

24.  Secondary:   Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline   [ Time Frame: Week 24, 52 ]

25.  Secondary:   Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline   [ Time Frame: Week 24, 52 ]

26.  Secondary:   Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline   [ Time Frame: Week 24, 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01458574     History of Changes
Other Study ID Numbers: A3921096
2011-004580-79 ( EudraCT Number )
OCTAVESUSTAIN ( Other Identifier: Alias Study Number )
Study First Received: October 21, 2011
Results First Received: April 7, 2017
Last Updated: April 7, 2017